Pharm. Margaret Obono, incumbent treasurer of the Pharmaceutical Society of Nigeria (PSN), has declared that the bulk of annual budget earmarked for the health sector is being spent on hospitalization, due to reported cases of adverse drug reaction (ADR).
Speaking on Essentials of Pharmacovigilance at a workshop organised for pharmacists by Pharmanews Limited on 4th April, 2013, Obono attributed this report to recent studies, saying that in addition to ADR, drug induced morbidity and mortality have also become a major problem for the health care professionals and the populace.
In defining adverse drug reaction, the former chairman of the Association of Lady Pharmacists (ALPS) described it as any response to a drug which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or the modification of physiological function.
“Other issues relevant to this science include substandard medicines, medication errors, lack of efficacy reports, use of medicines for indications that are not approved and for which there is inadequate scientific basis, as well as case reports of acute and chronic poisoning,” she said.
In her presentation, Obono noted that it was on the legal basis for Pharmacovigilance that the National Agency for Food and Drug Administration and Control (NAFDAC), which was established by Decree 15 of 1993 (as amended), came into existence.
NAFDAC as Act Cap N1 laws of the Federal Republic of Nigeria 2004 was placed with the mandate to “to control and regulate the manufacture, importation, exportation, distribution, advertisement, sale and use of food, drugs, cosmetics, chemicals/detergents, medical devices and all drinks, including packaged water.”
“This mandate further requires NAFDAC to ensure quality, safety and efficacy of the above named regulated products, hence, pharmacovigilance.Thus the National Pharmacovigilance Centre (NPC) was set up in September 2004,” she said.
The PSN treasurer further explained that since no active drug is entirely free from adverse effects, the introduction of an adverse drug reaction reporting system is an essential component of a national health care delivery system. Government shall, therefore, encourage the establishment of adequately equipped pharmacovigilanceunits nation-wide, to collect, evaluate and disseminate relevant information on adverse drug reactions and poisoning.
While discussing pharmacovigilance regulatory system in Nigeria, Pharm Obono opined that it shall be voluntary for the reporting health professionals and traditional herbal medicine practitioners or healthcare providers working in establishments other than the manufacturing or importing/distributing companies.
“ADR reporting is voluntary with no remuneration. It is a professional ethical obligation. In fact, it shall be mandatory for all manufacturers of pharmaceutical products and traditional herbal medicinal products, their local agents in Nigeria, importers, including those of public health medicines, to report to the National Pharmacovigilance Centre any adverse reaction associated with their products in Nigeria or anywhere in the world,’ she emphasised.
The pharmacist declared, among other things, that report on ADR should include response to medicines used in humans which are noxious (harmful) and unintended, lack of efficacy, overdose, misuse and/or abuse of a medicine, medication error and counterfeit or substandard medicine.